Patient Programmer for Implantable Drug Delivery Device

ABSTRACT

Methods for programming an implantable drug delivery device using a mobile computing device that include establishing a connection with a telemetry unit configured for wireless communication with the implantable drug delivery device, displaying user-selectable drug delivery settings for the implantable drug delivery device, receiving at least one selection of a drug delivery setting, translating the received selection into a signal format readable by the telemetry unit, and sending the translated signal to the telemetry unit to program the implantable drug delivery device. Further embodiments include telemetry units for communication with an implantable drug delivery device, and patient programmers and a method for patient modification to a programmed drug delivery regimen.

RELATED APPLICATION

This application claims the benefit of priority to U.S. ProvisionalApplication No. 62/148,431, titled “Patient Programmer for ImplantableDrug Delivery Device,” filed Apr. 16, 2015, the entire contents of whichare incorporated herein by reference.

FIELD

The present invention relates generally to systems and methods forprogramming an implantable drug delivery device.

BACKGROUND

Various implantable devices exist for delivering infusate, such asmedication, to a patient. One such device is an implantable valveaccumulator pump system. This system includes an electronicallycontrolled metering assembly located between a drug reservoir and anoutlet catheter. The metering assembly may include two normally closedsolenoid valves that are positioned on the inlet and outlet sides of afixed volume accumulator. The inlet valve opens to admit a fixed volumeof infusate from the reservoir into the accumulator. Then, the inletvalve is closed and the outlet valve is opened to dispense the fixedvolume of infusate from the accumulator to an outlet catheter throughwhich the infusate is delivered to the patient. The valves may becontrolled electronically via an electronics module, which canoptionally be programmed utilizing an external programmer to provide aprogrammable drug delivery rate. The external programmer is typically adedicated device used by medical professionals having a customizedtelemetry system for wirelessly communicating with the implantable drugdelivery device.

SUMMARY

Various embodiments include programming and controlling the operation ofimplantable drug delivery devices using a commonly-used mobile computingdevice, such as mobile phones, tablet computers, and PDA's. Variousembodiments also include telemetry units that may be physically coupledto a mobile computing device for programming of an implantable drugdelivery device by a physician or other medical professional, and mayalso be used with a patient programmer to allow patient-initiatedmodifications to a programmed drug delivery regimen within parametersset by the physician. The various embodiments leverage the flexibility,user-intuitiveness, processing power and networking capabilities ofcommonly-used mobile computing devices for programming and control of animplantable drug delivery system, while simplifying the requirements ofdedicated electronic devices associated with such systems.

Embodiments include a method for communicating with an implantable drugdelivery device using a mobile computing device that includesestablishing a connection with a telemetry unit configured for wirelesscommunication with the implantable drug delivery device, displayinguser-selectable drug delivery settings for the implantable drug deliverydevice, receiving at least one selection of a drug delivery setting,translating the received selection into a signal format readable by thetelemetry unit, and sending the translated signal to the telemetry unitto program the implantable drug delivery device. In some embodiments,the method may further include receiving data from the implantable drugdelivery device via the connection with the telemetry unit, such as dataregarding a status of the implantable drug delivery device,physiological data of a patient in which the drug delivery device isimplanted, or data regarding the programming of the implantable drugdelivery device.

Further embodiments include a patient programmer and a method forpatient modification to a programmed drug delivery regimen in animplantable drug delivery device that includes establishing a connectionwith a computing device, receiving from the computing device at leastone parameter for patient modification of the programmed drug deliveryregimen, storing the at least one parameter in a memory, detecting aninput event corresponding to a patient request for modification to theprogrammed drug delivery regimen, determining whether the requestedmodification is allowed based on the stored at least one parameter, andtransmitting the patient request to the implantable drug delivery devicewhen it is determined that the requested modification is allowed.

Further embodiments include a telemetry unit for communication with animplantable drug delivery device that includes a transmitter/receiverelement configured for wireless communication with the implantable drugdelivery device, a communication module for establishing a communicationlink with a mobile communication device, and a housing containing thetransmitter/receiver element and the communication module, the housingconfigured to secure the mobile communication device to the housing tophysically couple the mobile communication device to the telemetry unitwhile the communication link with the mobile communication device isestablished.

Further embodiments include a telemetry unit for communication with animplantable drug delivery device that includes a transmitter/receiverelement configured for wireless communication with the implantable drugdelivery device, a communication module for establishing a communicationlink with a patient programmer unit having a user-input componentconfigured to receive patient requests for modification to a drugdelivery regimen programmed in the implantable drug delivery device, anda housing containing the transmitter/receiver element and thecommunication module, the housing configured to the secure patientprogrammer unit to the housing to physically couple the mobilecommunication device to the telemetry unit while the communication linkwith the patient programmer unit is established.

Various embodiments include mobile computing devices and patientprogrammers configured to perform operations of the embodiment methodsdisclosed herein. Various embodiments also include mobile computingdevices and patient programmers including means for performing functionsof the embodiment methods disclosed herein. Various embodiments alsoinclude non-transitory processor-readable storage media having storedthereon processor-executable instructions configured to cause aprocessor to perform operations of the embodiment methods disclosedherein.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated herein and constitutepart of this specification, illustrate example embodiments of theinvention, and together with the general description given above and thedetailed description given below, serve to explain the features of theinvention.

FIG. 1A is a schematic diagram of a system for programming andcontrolling an implantable drug delivery device using a mobile computingdevice, a telemetry unit and a patient programmer unit.

FIG. 1B is a schematic diagram of a system for programming andcontrolling an implantable drug delivery device using a mobile computingdevice and a combined patient programmer/telemetry unit.

FIG. 1C is a schematic diagram of a system for programming andcontrolling an implantable drug delivery device using a first and secondmobile computing device and a telemetry unit.

FIG. 1D is a schematic diagram of a system for programming andcontrolling an implantable drug delivery device using a mobile computingdevice that interfaces with a first telemetry unit and a patientprogrammer that interfaces with a second telemetry unit.

FIG. 2 is a system block diagram of a mobile computing device usable invarious embodiments.

FIG. 3 is a process flow diagram illustrating an embodiment method forprogramming an implantable drug delivery device using a mobile computingdevice.

FIG. 4 is a process flow diagram illustrating an embodiment method forprogramming a patient programmer using a mobile computing device.

FIG. 5 is a process flow diagram illustrating an embodiment method ofprogramming a patient programmer with parameters for user modificationof a programmed drug delivery regimen.

FIG. 6 is a process flow diagram illustrating an embodiment method ofcontrolling operation of an implantable drug delivery device using apatient programmer.

FIGS. 7A-7G illustrate a telemetry unit usable for programming of aimplantable drug delivery device and for patient modifications to aprogrammed drug delivery regimen according to one embodiment.

FIGS. 8A-8G illustrate a telemetry unit according to another embodiment.

FIGS. 9A-9G illustrate a telemetry unit according to yet anotherembodiment.

FIGS. 10A-10G illustrate a telemetry unit according to yet anotherembodiment.

FIGS. 11A-11E are graphs illustrating alternative drug delivery regimensaccording to various embodiments.

DETAILED DESCRIPTION

The various embodiments will be described in detail with reference tothe accompanying drawings. Wherever possible, the same reference numberswill be used throughout the drawings to refer to the same or like parts.References made to particular examples and implementations are forillustrative purposes, and are not intended to limit the scope of theinvention or the claims.

The word “exemplary” is used herein to mean “serving as an example,instance, or illustration.” Any implementation described herein as“exemplary” is not necessarily to be construed as preferred oradvantageous over other implementations.

The terms “mobile computing device,” “mobile device,” and “mobilecommunication device” are used interchangeably herein to refer to anyone or all of tablet computers, smartphones, cellular telephones,personal digital assistants (PDA's), smartbooks, laptop computers,palm-top computers, and similar personal electronic devices whichinclude a programmable processor and memory and may include hardwareand/or software to enable communication with a telemetry unit forprogramming of an implantable drug delivery device.

Various embodiments include methods and systems for communicating withan implantable drug delivery device using a mobile computing device. Themobile computing device may include software, such as applicationsoftware, configured to execute on a processor of the mobile computingdevice to enable the device to establish a connection with a telemetryunit configured for wireless communication with an implantable drugdelivery device, display on a display of the mobile communication deviceuser-selectable drug delivery settings for the implantable drug deliverydevice, receive from a user interface of the mobile communication deviceat least one selection of a drug delivery setting, translate thereceived selection into a signal format that can be read by thetelemetry unit, and transmit the translated signals to the telemetryunit for programming of the mobile computing device. A mobile computingdevice executing the programming software may be used by medicalpersonnel to program an implantable device with an initial drug deliveryregimen, either before or after the device is implanted in the patient,and may also be used to re-program an implanted device with a new ormodified drug delivery regimen. In various embodiments, the softwareprocess executing on the mobile device may be configured to receive datafrom the implantable drug delivery device, via the telemetry unit, suchas current status data or historical data of the device (e.g., amount ofdrug dispensed and remaining to be dispensed, dosage history, etc.), aswell as physiological data of the patient. In some embodiments, thesoftware process executing on the mobile device may be used forinquiring an operational status (e.g., pump status) of the implantabledrug delivery device as a means to remotely determine the currentoperation of the implantable drug delivery device.

Various embodiments may also enable programming of a patient programmerusing a mobile computing device. A patient programmer may be a device,separate from the mobile computing device and usable by the patient toselectively modify a programmed drug delivery regimen within parametersset by the programming clinician. The mobile computing device mayinclude software, such as application software, configured to execute ona processor of the mobile computing device to enable the device toestablish a connection with a patient programmer device, display on adisplay of the mobile computing device user-selectable settings for thepatient programmer device, receive from a user interface of the mobilecomputing device at least one selection of parameter for patientmodification of a programmed drug delivery regimen, and transmit the atleast one parameter to the patient programmer device to program thepatient programmer device. Once programmed, the patient programmerdevice may be operable to selectively modify the programmed drugdelivery regime, such as by administering a bolus dose of the drug,within the parameters programmed by the mobile computing device.

Various embodiments are directed to a patient programmer device forenabling a patient to selectively modify the drug delivery regimen of animplantable drug delivery device within parameters set by medicalpersonnel. In embodiments, the patient programmer device may be asimple, easy-to-use device with limited functionality, such asfunctionality to enable a patient to administer an extra dose (i.e., abolus dose) of the drug when needed. The patient programmer may include,at minimum, a user input component (e.g., a button) and circuitryconfigured to detect a patient input event from the user input component(e.g., a button push) and to communicate an instruction to modify thedrug delivery regimen (e.g., by administering a bolus dose) to atelemetry unit configured for wireless communication with theimplantable drug delivery device. The patient programmer device mayfurther include communication circuitry configured to receive parametersrelated to allowable modifications to a programmed drug deliveryregimen, a memory for storing the received parameters, and a processor,coupled to the memory for determining whether or not a proposedmodification to the drug delivery regimen corresponding to a detectedpatient input event (e.g., a button push) is allowed based on the storedparameters. The patient programmer may also include a user feedbackcomponent, such as a display (e.g., an LCD screen, LED indicator(s), atouchscreen display, etc.) that may indicate whether or not a proposeduser modification to the drug delivery regimen (e.g., a button push torequest a bolus dose) was allowed and/or successfully implemented. Inembodiments, a display of a patient programmer may also displayinformation regarding the implantable drug delivery device and/or theprogrammed drug delivery regimen, such as current status data orhistorical data of the device (e.g., amount of drug dispensed andremaining to be dispensed, dosage history, existence of a faultcondition, etc.), as well as physiological data of the patient.

In various embodiments, the patient programmer device may be physicallycoupled to a telemetry unit configured for wireless communication withthe implantable drug delivery device. In embodiments, the patientprogrammer device may be removably coupled to the telemetry unit. Thetelemetry unit may be the same unit or a different unit than thetelemetry unit used by the clinician mobile computing device forprogramming of the implantable drug delivery device. In someembodiments, the patient programmer device may be integral with thetelemetry unit (i.e., it is not removably coupled to the telemetryunit). In some embodiments, the patient programmer may be a separatedevice, such as a mobile computing device (e.g., a phone, tabletcomputer, etc.) or a dedicated patient programmer unit having a feedbackcomponent and a patient input mechanism (e.g., a touchscreen display),useable by the patient and configured with software instructions toenable the device to receive and store parameters related to allowablemodifications to a programmed drug delivery regimen, and to communicatewith a separate telemetry unit to transmit instructions to modify thedrug delivery regimen when authorized by the stored parameters.

Various embodiments are directed to a telemetry unit for an implantabledrug delivery device. The telemetry unit may include a communicationcircuit for providing a communication interface with a mobile computingdevice, a transmitter/receiver component (e.g., a magnetic coil) forwireless signal communication with the implantable drug delivery device,and a processor and associated memory (e.g., a buffer) configured toprovide a communication interface with the implantable drug deliverydevice.

The telemetry unit may further comprise a housing that may be coupled toa mobile computing device such that while the mobile computing device iscoupled to the housing, the telemetry unit may establish a communicationlink with the mobile computing device. In some embodiments, the mobilecomputing device may be received by the housing and physically coupledto the telemetry unit during programming of an implantable drug infusiondevice, and may be removed from the housing after the implantable deviceis programmed.

In various embodiments, the telemetry unit may comprise a housing thatmay be coupled to a patient programmer component configured to enable apatient to selectively modify the drug delivery regimen of animplantable drug delivery device within parameters set by medicalpersonnel. In some embodiments, the same telemetry unit may be used withboth the mobile computing device during programming of the implantabledrug infusion device and the patient programmer. For example, once theimplantable drug delivery device is programmed and the mobile computingdevice is removed from the housing, a patient programmer component maybe inserted into the housing. The patient programmer component mayinclude, for example, a user input component (e.g., a button) andcircuitry configured to detect a patient input event from the user inputcomponent (e.g., a button push) and to communicate an instruction tomodify the drug delivery regimen (e.g., by administering a bolus dose)to the wireless transmitter/receiver component of the telemetry unit.The patient programmer component may also include a user feedbackcomponent, such as a display (e.g., an LCD screen, LED indicator(s),etc.) that may indicate whether or not a proposed user modification tothe drug delivery regimen (e.g., a button push to request a bolus dose)was allowed and/or successfully implemented. The telemetry unit and/orthe patient programmer component may further include communicationcircuitry configured to receive parameters related to allowablemodifications to a programmed drug delivery regimen, a memory forstoring the received parameters, and a processor, coupled to the memoryfor determining whether or not a proposed modification to the drugdelivery regime corresponding to a detected patient input event (e.g., abutton push) is allowed based on the stored parameters. When theproposed modification is allowed, the telemetry unit may transmit theinstruction to the implantable drug delivery device.

In an alternative embodiment, the patient programmer component is notremovable from the housing but may be an integral part of the telemetryunit.

In further embodiments, a first telemetry unit telemetry unit maycomprise a housing adapted to receive a mobile computing device suchthat while the mobile computing device is received by the housing, thetelemetry unit may establish a communication link with the mobilecomputing device for programming of the drug infusion device. A secondtelemetry unit may comprise a housing adapted to receive a patientprogrammer component configured to enable a patient to selectivelymodify the drug delivery regimen of an implantable drug delivery devicewithin parameters set by medical personnel.

Various embodiments enable leveraging the flexibility,user-intuitiveness, processing power and networking capabilities ofcommonly-used mobile computing devices, such as mobile phones, tabletcomputers and PDA's, for programming and control of an implantable drugdelivery system, while simplifying the requirements of dedicatedelectronic devices associated with such systems.

FIG. 1A illustrates a system 100 for programming an implantable drugdelivery device 101 using a mobile computing device 301 according to oneaspect of the invention. FIG. 1A schematically illustrates a patient 10with an implantable drug delivery device 101 and an external telemetryunit 201 for communicating with the implantable drug delivery device 101while it is inside the patient 10. The patient 10 may be a mammalianpatient, such as a human. The implantable drug delivery device 101 maycommunicate with the implantable drug delivery device over a wirelesslink 203. In one embodiment, the wireless link 203 uses a magnetic-basedpulse position modulation (PPM) protocol, although other technologiesand protocols could be utilized.

The implantable drug delivery device 101 may include a drug reservoir103, a drug infusion pump 105, an internal controller 107 (e.g., aprocessor 109 and associated memory 111) that is configured to controlthe operation of the drug infusion pump 105, a wireless transceiver 113for providing two-way communication between the internal controller 107and the external telemetry unit 201, one or more sensors 115 thatprovide data to the controller 107 regarding conditions of the drugdelivery device 101 and/or physiological conditions of the patient 10(e.g., body temperature, heart rate, etc.), and a power source 117(e.g., a battery), all of which may be housed in a biocompatible orbio-inert housing 119. The drug delivery device 101 further includes anoutlet 121 for delivering metered doses of a drug to the patient 10,which may be via a delivery catheter 123 extending from the outlet 121to one or more drug delivery sites 12 in target tissue.

The internal controller 107 controls the operation of the drug deliverydevice 101 by actuating the drug infusion pump 105, which may be a valveaccumulator pump, based on control regimens (e.g., codes and commands)stored in memory 111 and executed by the processor 109 of the internalcontroller 107. The control regimens are executed to activate the druginfusion pump 105 so as to automatically dispense the drug from the drugreservoir 103 in accordance with a prescribed duration, flow rate orother parameters of drug delivery.

The internal controller 107 may also receive data from the sensors 115and may use the sensor data to adjust, start or terminate the deliveryof drugs. The manner in which the controller responds to sensor data maybe prescribed by the stored control regimen.

The internal controller 107 may also be configured to receive a new,modified or updated drug delivery control regimen over the wireless link203 from the external telemetry unit 201, and to store a received new,modified or updated drug delivery control regimen in the memory 111 ofthe controller 107. The controller 107 may then operate the druginfusion pump 105 to deliver the drug in accordance with the new,modified or updated control regimen. In this way, the implantable drugdelivery device 101 may be programmed and/or re-programmed remotely overthe wireless link 203, including when the device 101 is implanted intissue of a patient 10. The internal controller 107 may also receiveperiodic commands from the patient 10 to modify the programmed drugdelivery control regimen, such as by delivering a bolus dose of the drugto the patient, as described below. The internal controller 107 may alsobe configured to send data to another device over the wireless link 203,such as data related to the status of the device 101 (e.g., dosagehistory, amount of drug delivered and amount remaining in drugreservoir, remaining power, device malfunctions, etc.) and/orphysiological data of the patient 10.

The telemetry unit 201 may be located external to the patient 10, andmay include a wireless transmitter/receiver element 205, such as amagnetic coil, for communicating with the drug delivery device 101 overthe wireless link 203. The telemetry unit 201 may include a housing 207containing the transceiver 205 and associated circuitry, as well as apower supply 209 (e.g., one or more batteries). In embodiments, thetelemetry unit 201 may be a portable unit that is designed to bemaintained in close proximity to the patient 10 and within wirelessrange of the implanted drug delivery device 101, and may be, forexample, carried or worn by the patient 10, or affixed to the skin ofthe patient 10.

The telemetry unit 201 may include a communication circuit 215 toprovide a communication interface 217 with another device, such as themobile computing device 301 shown in FIG. 1A. The communicationinterface 217 with the mobile computing device 301 may be via a physical(e.g., wire, cable, plug, etc.) connection, such as a USB connection.Alternatively or in addition, the interface 217 may be a wirelessinterface, including a short-range wireless interface, such as aPersonal Area Network (PAN) interface using a IEEE 802.15x standard(e.g., a BLUETOOTH® interface), or a near-field wireless interface. Thetelemetry unit 201 may further include a control processor 211 andmemory 213 (e.g., an input/output buffer) to provide modulation anddemodulation of signals sent to and from wireless transmitter/receiver205. Thus, in various embodiments, the telemetry unit 201 may provide abridge for communication between the implantable drug delivery device101 and a mobile computing device 301, such that that the mobilecomputing device 301 may communicate with and program the implantabledrug delivery device 101, as described below.

The telemetry unit 201 may be configured to be physically coupled to themobile computing device 301. For example, the housing 207 of thetelemetry unit 201 may include an opening 219, such as a cavity, slot,recess, cradle, etc., that may be configured to receive the mobilecomputing device 301 such that the mobile computing device 301 may bephysically coupled to the telemetry unit 201. In some embodiments, thetelemetry unit 201 may include one or more features that may beconfigured to be received in an opening in the mobile computing device301 to physically couple the mobile computing device 301 to thetelemetry unit 201. For example, the housing 207 of the telemetry unit201 may include a plug, such as a USB plug, that may plug into a USBport on the mobile computing device 301. As discussed above, in variousembodiments the communication interface 217 between the mobile computingdevice 301 and the telemetry unit 201 may be a short-range interface(e.g., 10 meters or less, such as 5 meters or less), and in the case ofa near-field interface or a physical connector interface, the devicesmay need to be in relatively close proximity (e.g., ˜5 cm or less), oreven physically contacting each other, in order to establish aconnection. This may serve an important safety function, since requiringthe devices to be in relatively close proximity to establish aconnection may minimize the possibility that the mobile computing device301 will unintentionally establish a connection with any telemetry unitother than the telemetry unit 201 associated with the implantable drugdelivery device 101 to be programmed. Providing a physical couplingbetween the mobile computing device 301 and the telemetry unit 201during programming of the implantable device 101 helps ensure that themobile computing unit 301 and telemetry unit 201 establish a robustconnection for transfer of programming and other data that will not beinterrupted during the programming of the implantable device 101.

The system 100 may also include a mobile computing device 301 configuredto program the implantable infusion device 101. The mobile computingdevice 301 may be a typical portable computing device (e.g., smartphone,tablet, etc.) with communication capabilities for transmitting andreceiving data over a communication network 303, such as a cellulartelephone network, a radio access network, a WiFi network, a WiMAXnetwork, etc. In one example, as shown in FIG. 1A, the communicationnetwork 303 is a cellular telephone network that includes a plurality ofaccess points 305 (e.g., base stations) coupled a network operationscenter 308 which may operate with other network infrastructure (e.g.,servers, routers, etc., not shown) to connect the mobile computingdevice 301 to other network destinations, such as a server 331, whichmay be via telephone land lines (e.g., a POTS network, not shown) and/orthe Internet 307. Communications between the mobile computing device 301and the communication network 303 may be accomplished via a two-waywireless communication link 309, which may use 4G, 3G, CDMA, TDMA, LTEand/or other technologies.

Alternatively or in addition, the communication network 303 may be alocal area network (LAN) or campus network, such as a private hospitalnetwork. The mobile computing device 301 may communicate with networkaccess point(s) 305 via a short or medium range wireless communicationlink, such as a IEEE 801.11 standard (e.g., WiFi) or BLUETOOTH® link.The network 303 may optionally provide access to an external wide-areanetwork (WAN), such as the Internet 307.

A typical mobile computing device 301 for use in the various embodimentsmay include the components illustrated schematically in FIG. 2. Forexample, mobile computing device 301 may include a processor 311 coupledto internal memory 313 and to a display 315. Additionally, the mobilecomputing device 301 may have an antenna 317 for sending and receivingelectromagnetic radiation that is connected to a wireless data linkand/or cellular telephone transceiver 319 coupled to the processor 311.In some embodiments, the transceiver 319 and portions of the processor311 and memory 313 used for cellular telephone communications may becollectively referred to as the air interface. The mobile computingdevice 311 may further include one or more additional communicationmodules 321, 323, 325 coupled to the processor 311, such as a USBcommunication module 321, which may include a USB port and associatedcontrol circuitry, a PAN communication module 323, which may include awireless PAN (e.g., BLUETOOTH®) transmitter/receiver and associatedcontrol circuitry, and a near-field communication (NFC) module 325,which may include a NFC transmitter/receiver and associated controlcircuitry. The mobile computing device 301 may also include a user inputcomponent 327 coupled to the processor 311, which may be, for example, atouchscreen user interface, a keypad and/or one or more buttons orswitches.

The processor 311 may be any programmable microprocessor, microcomputeror multiple processor chip or chips that can be configured by softwareinstructions (applications) to perform a variety of functions. In somedevices, the processor 311 may include internal memory sufficient tostore the application software instructions. In many mobile computingdevices, the internal memory 313 may be a volatile or nonvolatile memorysuch as flash memory, or a mixture of both. For the purpose of thisdescription, a general reference to memory includes all memoryaccessible to the processor 311, including internal memory 313,removable memory plugged into the mobile computing device, and memorywithin the processor 313 itself.

The system 100 may also include a patient programmer unit 401, as shownin FIG. 1A. The patient programmer unit 401 may be usable by the patient10 to selectively modify the drug delivery regimen of an implantabledrug delivery device 101 within parameters set by a physician or othermedical clinician. In some embodiments, the patient programmer unit 401may be a simple, easy-to-use device with limited functionality, such asfunctionality to enable a patient to administer an extra dose (i.e., abolus dose) of the drug when needed.

As schematically illustrated in FIG. 1A, the patient programmer unit 401may include an internal controller 403 (e.g., a processor 405 andassociated memory 407), a user input component 409 coupled to thecontroller 403, and a display 411 coupled to the controller 403. Theuser input component 409 may be as simple as a button that a user maypush to request the administration of a bolus dose of medication. Othermore complex user input components can also be utilized. Similarly, thedisplay 411 may be a relatively simple, low-cost display, such as an LCDscreen, LED indicator(s), and/or audio alarm(s), that provides thepatient with feedback regarding the operations of the patient programmerunit 401, such as whether or not request for a bolus dose is successful.

In some embodiments, the patient programmer unit 401 may resemble atypical mobile communication device (e.g., a smartphone) but withlimited functionality. For example, the display 411 of the patientprogrammer unit 401 may be a touchscreen display that may also functionas a user input component 409. The patient programmer unit 401 may alsoinclude additional input component(s) 409, such as one or more hardkeys, switches, buttons, etc. In some embodiments, the user inputcomponent 409 may comprise circuitry that detects a user input eventexternal to the patient programmer unit 401, such as a push of a buttonor hard key located on the telemetry unit 201. The patient may use thepatient programmer unit 401 to selectively modify the drug deliveryregimen of the implantable drug delivery device 101 within prescribedparameters (e.g., request a bolus dose) as well as to displayinformation regarding the implantable drug delivery device and/or theprogrammed drug delivery regimen, such as current status data orhistorical data of the device (e.g., amount of drug dispensed andremaining to be dispensed, dosage history, existence of a faultcondition, etc.), and physiological data of the patient when such datais available.

The patient programmer unit 401 may also include a communication module413 coupled to the processor 405 that enables the patient programmerunit 401 to communicate with at least one other device. For example, thecommunication module 413 may enable the patient programmer unit 401 toestablish a wired (e.g., USB) or wireless (e.g., near-fieldcommunication (NFC), personal area network (PAN) communication such asBLUETOOTH®, etc.) communication link 415 with the telemetry unit 201 fortransmitting commands to the telemetry unit 201 (e.g., in response to abutton push) for relay to the implantable drug delivery device 101. Thepatient programmer 401 may also receive feedback from the telemetry unit201 regarding the status of a command (e.g., whether it was successfullytransmitted to the implantable device 101, whether a requested bolusdose was successfully administered, etc.). The communication module 413may also establish a wired or wireless communication link 417 with themobile computing device 301 for programming of the patient programmerunit 401. In some embodiments, the patient programmer unit 401 mayinclude an antenna and transceiver, such as shown in FIG. 2, and may becapable of communicating with distant servers 331 and/or making aconnection with the Internet 300 via a wireless telecommunicationnetwork 303 (e.g., via wireless communications with a network 305, 308).

The controller 403 of the patient programmer unit 401 may be configuredto receive parameters related to allowable modifications to a programmeddrug delivery regimen, and to store such received parameters in memory407. The parameters may include, for example, a total number of bolusdoses that may be requested by the patient, the number of bolus dosesthat may be requested in a given time period, a minimum wait timebetween successive requests for bolus doses, the volume of each bolusdose, etc. When the patient 10 inputs a request to modify the programmeddrug delivery regimen (e.g., by requesting a bolus dose), the processor405 of the patient programmer device 401 may be configured to eitherallow or deny the request, in accordance with the parameters stored inmemory 407, and to indicate on the display 411 whether the request wasallowed.

The patient programmer unit 401 may be configured to be physicallycoupled to the telemetry unit 201. In some embodiments, the patientprogrammer unit 401 may be sized and shaped so as to be received in theopening 219 of the housing 207 of the telemetry unit 201. Thus, afterthe mobile computing device 301 is finished programming the implantabledrug delivery device 101, the mobile computing device 301 may be removedfrom the housing 207 of the telemetry unit 201 and the patientprogrammer unit 401 may be inserted into the opening 219 of the housing207. The patient programmer unit 401 may be programmed withpatient-modification parameters by the mobile computing device 301 atany time during the programming process, including either before orafter the patient programmer unit 401 is placed into the opening 219 ofthe telemetry unit housing. After programming is complete, the patientprogrammer unit 401, coupled to the telemetry unit 201, may be providedto the patient 10 and used by the patient to request modifications tothe programmed drug delivery regimen, in accordance with the storedpatient modification parameters.

In an alternative embodiment, the telemetry unit 201 and patientprogrammer unit 401 may be combined into an integrated patientprogrammer/telemetry unit 501, as shown in FIG. 1B. In this embodiment,a mobile computing device 301 may be coupled to the combined patientprogrammer/telemetry unit 503, such as by being received in an opening503 of the combined patient programmer/telemetry unit 503, forprogramming of both the implantable drug delivery device 101 and thepatient programmer component of the combined patientprogrammer/telemetry unit 501.

The combined patient programmer/telemetry unit 501 may include atransmitter/receiver element 511 for communicating with the implantabledrug delivery device 101 via wireless link 203, a controller 505, whichmay include a processor 507 and memory 505, and a communication module513 for establishing a wired or wireless link 217 with a mobilecomputing device 301 for programming of the implantable drug deliverydevice 101 and for programming of patient modification parameters, whichmay be stored in the memory 505 of the unit 501. The unit 501 may alsoinclude a user input component 513 to enable the patient 10 to request apatient modification to the drug delivery regimen (e.g., a bolus dose)and a display 515 to display a status of the unit 501. All thesecomponents may be housed in a common housing 519, which may also includean internal power supply 517 (e.g., a battery).

In yet another alternative embodiment, the above-described patientprogrammer functionality may not be provided by a dedicated device, suchas patient programmer unit 401 shown in FIG. 1A, but may instead beprovided by a second mobile computing device 601, as shown in FIG. 1C.The second mobile computing device 601 may be a typical portablecomputing device (e.g., smartphone, tablet, etc.) that may include thecomponents illustrated in FIG. 2. The second mobile computing device 601may be configured with software (e.g., application software) to enablethe patient to selectively modify the drug delivery regimen of animplantable drug delivery device 101 within parameters set by aphysician or other medical clinician. The parameters may be receivedfrom the first mobile computing device 301 and stored in the memory ofthe second device 601. The parameters may be received over a wired orwireless link 603 between the first and second mobile computing devices301, 601. In some embodiments, the parameters or updated parameters maybe received remotely over a link 607 with communications network 303.The parameters may be received from the first mobile computing device301 or from another network 303 resource or node, including from theInternet 307. The second wireless computing device 601 may be configuredto provide a wired or wireless link 605 to the telemetry unit 201 fortransmitting instructions to modify the programmed drug delivery regimen(e.g., by administering a bolus dose) to the implantable drug deliverydevice 101. Executable software on the second mobile computing device601, which may be downloaded to the device 601 over communicationnetwork 303, may enable the patient 10 to input requests to modify theprogrammed drug delivery regimen via the user interface of the secondmobile computing device 601. The second mobile computing device 601 maybe physically coupled to the telemetry unit 201, such as by beinginserted into an opening 219 in the housing 207 of the telemetry unit201, to help ensure a robust connection between the second mobilecomputing device 601 and the telemetry unit 201 for communicatingpatient requests to the implantable drug delivery device 201.

In some embodiments, the second mobile computing device 601 may be usedto program the implantable drug delivery device 101 with a new orupdated drug delivery regimen. The drug delivery regimen may be receivedat the second mobile computing device 601 over the network 303, and maybe received from another device, such as first mobile computing device301, used by a physician or other medical professional. The receiveddrug delivery regimen may be transmitted from the second mobilecomputing device 601 to the implantable drug delivery device 101 forprogramming of the device 101 via the telemetry unit 201.

In yet another alternative embodiment, two separate telemetry units201A, 201B may be utilized as shown in FIG. 1D. Each telemetry unit201A, 201B may be similar to the telemetry unit 201 described above inconnection with FIG. 1A. A first telemetry unit 201A may have acommunication circuit 215A configured to provide a communicationinterface 217 with the mobile computing device 301 for programming ofthe implantable drug infusion device 101 as described above. The housing207A of the first telemetry unit 201A may include an opening 219A thatis configured to receive the mobile computing device 301 such that themobile computing device 301 may be physically coupled to the telemetryunit 201. The second telemetry unit 201B may have a communicationcircuit 215B to provide a communication interface 415 with the patientprogrammer unit 401 to enable the patient to request modifications tothe programmed drug delivery regimen as described above. A housing 207Aof the second telemetry unit 201B may include an opening 219B that isconfigured to receive the patient programmer unit 401 such that thepatient programmer unit 401 may be physically coupled to the secondtelemetry unit 201B. Alternately, the patient programmer unit 401 may beintegral with the second telemetry unit 201B.

FIG. 3 is a process flow diagram illustrating an embodiment method 700for programming an implantable drug delivery device, such as device 101shown in FIGS. 1A-D. The method 700 may be performed by a mobilecomputing device 301, such as shown in FIGS. 1A-2, and in particular bya processor 311 of a mobile computing device 301 that is configured withprocessor-executable software instructions that may be stored in amemory 313 of the device. The software instructions may be applicationsoftware that may be downloaded to the mobile computing device 301 overa communications network (e.g., network 303 and/or Internet 307 in FIGS.1A-D), and may be downloaded from a server 331. In various embodiments,a downloadable version of application software allows general purposecomputing devices to download and run the software that providesfunctionality for programming of implantable drug delivery devices. Inother embodiments, the mobile computing device 301 may havefactory-installed application software for supporting the deviceprogramming functions.

In block 701 of method 700, the mobile computing device 301 mayestablish a connection with a telemetry unit configured for wirelesscommunication with an implantable drug delivery device. As shown inFIGS. 1A-D, for example, the mobile computing device 301 may establish aconnection to the telemetry unit 201, 501, 201A via a wired or wirelesslink 217, such as via a USB connection, a wireless PAN (e.g.,BLUETOOTH®) connection, or a near field communication (NFC) connection.The establishing of a connection with the telemetry unit may occursubstantially simultaneously with a physical coupling of the mobilecomputing device 301 and the telemetry unit, such as by placing themobile computing device 301 within an opening 219, 503, 219A of thetelemetry unit 201, 501, 201A.

The establishing of a connection with the telemetry unit may optionallyinclude an authentication process to ensure that the mobile computingdevice 301 and/or the user of the device 301 is authorized tocommunicate with and program the implantable drug delivery device 101.For example, the mobile computing device 301 may provide credentials(e.g., an identifier, security key, password, etc.) to the telemetryunit 201, 501, 201A and/or to the implantable device 101 which may bechecked by logic on the telemetry unit 201, 501, 201A or the implantabledevice 101 to ensure that the mobile device 301 and/or the user of thedevice, which is typically a physician or other medical professional, isauthorized to program the device. In embodiments, the authenticationprocess, or portions thereof, may be performed remotely over thecommunication network 303. For example, the mobile computing device 301may communicate over the network 303 with a server 331, and may providethe server 331 with identifying information regarding the mobilecomputing device 301 and/or the user of the device, as well asidentifying information regarding the implantable device 101 and/or thepatient 10. The server 331 may be configured to access a database todetermine whether the mobile computing device 301 and/or the user of thedevice 301 is authorized to program the drug delivery device 101implanted in the patient 10. When the mobile device 301 and user areauthorized, the server 331 may transmit authorization data, which couldinclude a security key, a software plug-in, etc., that enables theprogramming of the implantable device 101 to proceed.

In optional block 703 of method 700, the mobile computing device 301 mayreceive data from the implantable drug delivery device 101. The data maybe sent from the implantable drug delivery device 101 to the telemetryunit 201, 501, 201A via wireless connection 203, and passed to themobile computing device 301 over the connection 217 with the telemetryunit 201, 501, 201A. The data may relate to the status of theimplantable drug delivery device 101 (e.g., dosage history, amount ofdrug delivered and amount remaining in drug reservoir, remaining power,device malfunctions, etc.) and/or physiological data of the patient 10,which may be useful to the physician when programming the implantabledevice 101 with a new or updated drug delivery regimen.

In block 705 of method 700, the mobile computing device 301 may displayuser-selectable drug delivery settings for the implantable drug deliverydevice 101. The user-selectable settings may be displayed in a graphicaluser interface on a display screen of the mobile computing device 301,for example. In embodiments, the application software running on themobile computing device 301 may be configured to walk the physicianthrough the process of creating a new or modified drug delivery regimenfor the patient. At least one selection of a drug delivery setting maybe received at block 707. The drug delivery settings may be entered by aphysician or other authorized clinician using the user interfacecomponent of the mobile computing device 301, which may be a touchscreeninterface, a keypad, or the like. The at least one selection of a drugdelivery setting may comprise a new or updated drug delivery regimen.

In block 709, the received selection(s) may be translated into a signalformat that is readable (i.e., able to be understood) by the telemetryunit 201, 501, 201A. In block 711, the translated signals correspondingto the received selection(s) are sent to the telemetry unit 201, 501,201A. The telemetry unit 201, 501, 201A may then forward the signalsover the wireless link 203, 203A to the implantable drug delivery device101 for programming of the device 101.

In optional block 713, the mobile computing device 301 may receiveconfirmation from the implantable drug delivery device 101 that thedevice 101 has been successfully programmed. The confirmation messagemay be sent from the implantable drug delivery device 101 to thetelemetry unit 201, 501, 201A via wireless connection 203, 203A andpassed to the mobile computing device 301 over the connection 217 withthe telemetry unit 201, 501, 201A. Additionally, the telemetry device201, 501, 201A and/or the implantable drug delivery device 101 may senda message indicating that an attempted programming failed.

Following programming of the implantable drug delivery device 101, theconnection between the mobile computing device 301 and the telemetryunit 201, 501, 201A may be ended in block 715. The mobile computingdevice 301 may be physically de-coupled from the telemetry unit 201,501, 201A. The implantable drug delivery device 101 may deliver drug(s)to the patient in accordance with the programmed drug delivery regimen.

As described above and illustrated in FIGS. 1A-1D, the mobile computingdevice 301, which is configured to provide a programming interface withthe telemetry unit 201, may be capable of communicating with distantservers 331 and making a connection with the Internet 300 via a wirelesstelecommunication network 303 (e.g., via wireless communications 309with a cellular network 305, 308). Thus, once the mobile computingdevice 301 has established a connection with a patient programmer 401(e.g., FIG. 1A) or a combined patient programmer/telemetry unit 501(e.g., FIG. 1B) in block 701, data from the patient programmer and/ortelemetry unit may be relayed via the wireless telecommunication network303 in block 703 to a computing device of a physician at a remotelocation for display in block 705. For example, a physician may login toa website hosted by a server 331 that enables the physician to receiveinformation relayed by the mobile computing device 301, such as currentuser-selectable drug delivery settings. Further information that may berelayed to a physician's computing device at a remote location mayinclude patient vital signs as may be sensed by the implantable drugdelivery device 101, fluid levels of one or more reservoirs within theimplantable drug delivery device 101, and/or electronic status anddiagnostic information that may be relayed by the implantable drugdelivery device 101.

Using the network accessibility provided by the mobile computing device301 and telecommunication networks, a physician and a remote locationmay interact with a display of programming options for the patientprogrammer, such as interacting with the website hosted by a server 331.Thus, the mobile computing device 301 may receive selections of drugdelivery settings from the physician in block 707 via communicationsfrom a distant computer (e.g., the Internet). This capability enablesphysicians to remotely diagnose, reprogram and otherwise manage thepatient's implantable drug delivery device 101 and/or patient programmer201, 401, 501 without requiring the patient to come to the doctor'soffice. In many situations, this capability may enable faster and moreeffective care than possible with devices that must be programmedlocally.

FIG. 4 is a process flow diagram illustrating an embodiment method 800for programming a patient programmer unit, such as a patient programmerunit 401 as shown in FIGS. 1A and 1D, a combined patientprogrammer/telemetry unit 602 as shown in FIG. 1B, or a mobile computingdevice 601 configured with patient programmer functionality as shown inFIG. 1C. The method 800 may be performed by a mobile computing device301, such as shown in FIGS. 1A-D, and in particular by a processor 311of a mobile computing device 301 that is configured withprocessor-executable software instructions that may be stored in amemory 313 of the device, as schematically shown in FIG. 2. The softwareinstructions may be application software that may be downloaded to themobile computing device 301 over a communications network (e.g., network303 and/or Internet 307 in FIGS. 1A-D), and may be downloaded from aserver 331. In various embodiments, a downloadable version ofapplication software allows general purpose computing devices todownload and run the software that provides functionality forprogramming of patient programmer devices. In other embodiments, themobile computing device 301 may have factory-installed applicationsoftware for supporting the programming functions. The software forperforming the method 800 of FIG. 4 may be the same as or different fromsoftware for programming an implantable drug delivery device, such asdescribed above in connection with method 700 of FIG. 3.

In block 801 of method 800, the mobile computing device 301 mayestablish a connection with a patient programmer, such as patientprogrammer unit 401 shown in FIGS. 1A and 1D, combined patientprogrammer/telemetry unit 501 shown in FIG. 1B or a second mobilecomputing device 601 configured with a patient programmer functionalityas shown in FIG. 1C. The mobile computing device 301 may establish aconnection to the patient programmer via a wired or wireless link 415,217, 603 such as via a USB connection, a wireless PAN (e.g., BLUETOOTH®)connection, or a near field communication (NFC) connection. Inembodiments in which the patient programmer is network enabled, themobile communication device 301 may establish the connection via atelecommunications network 303 and/or the Internet 307.

The establishing of a connection with the patient programmer mayoptionally include an authentication process to ensure that the mobilecomputing device 301 and/or the user of the device 301 is authorized tocommunicate with and program the patient programmer 401, 501, 601. Forexample, the mobile computing device 301 may provide credentials (e.g.,an identifier, security key, password, etc.) to the patient programmer401, 501, 601 which may be checked by logic on the patient programmer401, 501, 601 to ensure that the mobile device 301 and/or the user ofthe device 301, which is typically a physician or other medicalprofessional, is authorized to program the patient programmer withparameters for patient modification of a drug delivery regimen. Inembodiments, the authentication process, or portions thereof, may beperformed remotely over the communication network 303. For example, themobile computing device 301 may communicate over the network 303 with aserver 331, and may provide the server 331 with identifying informationregarding the mobile computing device 301 and/or the user of the device,as well as identifying information regarding the patient programmer 401,501, 601 and/or the patient 10. The server 331 may be configured toaccess a database to determine whether the mobile computing device 301and/or the user of the device 301 is authorized to program the patientprogrammer 401, 501, 601 with parameters for patient modification of adrug delivery regimen. When the mobile device 301 and user areauthorized, the server 331 may transmit authorization data, which couldinclude a security key, a software plug-in, etc., that enables theprogramming of the patient programmer 401, 501, 601 to proceed.

In block 803 of method 800, the mobile computing device 301 may displayuser-selectable settings for the patient programmer. The user-selectablesettings may be displayed in a graphical user interface on a displayscreen of the mobile computing device 301, for example. In embodiments,the application software running on the mobile computing device 301 maybe configured to lead the physician through the process of settingparameters for patient modification to a programmed drug deliveryregimen stored in an implantable drug delivery device 101. For example,the parameters may relate to the number of bolus doses of a drug that apatient may request in a predetermined time period, the volume of drugadministered per bolus, a minimum wait time between administering bolusdoses, time(s) of day in which bolus doses may be administered, anallowable modification to a basal rate of drug delivery that a patientmay request, etc. The user of the mobile computing device 301 may entervarious parameters relating to allowable patient modifications, and aselection of at least one parameter for patient modification of aprogrammed drug delivery regimen may be received at block 805. Theselection may be entered using the user interface component of themobile computing device 301, which may be a touchscreen interface, akeypad, or the like.

In block 807, the selected parameter(s) may be transmitted to thepatient programmer 401, 501, 601 to program the patient programmer withthe selected parameter(s). In embodiments, the selected parameter(s) maybe transmitted directly to the patient programmer 401, 501, 601 via alink 415, 217, 603. In other embodiments, the selected parameter(s) maybe transmitted to another device, such as the telemetry unit 201 or theimplantable drug delivery device 101. The selected parameter(s) may betransmitted while the mobile computing device 301 programs theimplantable device 101, for example. The parameter(s) may be stored atleast temporarily on the other device and later sent to the patientprogrammer.

In optional block 809, the mobile computing device 301 may receiveconfirmation from the patient programmer 401, 501, 601 that the patientprogrammer has been successfully programmed. Additionally, the patientprogrammer 401, 501, 601 may send a message indicating that an attemptedprogramming failed.

Following programming of the patient programmer 401, 501, 601, theconnection between the mobile computing device 301 and the patientprogrammer 401, 501, 601 may be ended in block 811. The patientprogrammer 401, 501, 601 may be used to modify a programmed drugdelivery regimen of the implantable drug delivery device 101 inaccordance with the parameters programmed by the mobile computing device301.

FIG. 5 is a process flow diagram illustrating an embodiment method 900of programming patient modification parameters. The method 900 may beperformed in parallel with method 800 shown in FIG. 4. The method 900 ofFIG. 5 may be performed by a patient programmer, such as a patientprogrammer unit 401 as shown in FIGS. 1A and 1D, a combined patientprogrammer/telemetry unit 501 as shown in FIG. 1B, or a mobile computingdevice 601 configured with patient programmer functionality as shown inFIG. 1C. Alternatively, the method 900 may be performed by theimplantable drug delivery device 101, and the logic for determiningwhether a requested patient modification to the programmed drug deliveryregimen is permitted may reside on the implantable device 101 itself.

In block 901 of method 900, a connection may be established with amobile computing device, such as mobile computing device 301 shown inFIGS. 1A-1D. In block 903, at least one parameter for patientmodification of a programmed drug delivery regimen is received. The atleast one parameter may relate to the number of bolus doses of a drugthat a patient may request in a predetermined time period, the volume ofdrug administered per bolus, a minimum wait time between administeringbolus doses, time(s) of day in which bolus doses may be administered, anallowable modification to a basal rate of drug delivery that a patientmay request etc. In block 907, the at least one parameter may be storedin a memory of the patient programmer.

In block 905, the at least one received parameter may be stored inmemory, such as in internal memory 407 of a patient programmer unit 401.In optional block 907, a confirmation may be sent to the programmingmobile computing device 301 that the programming of the parameters wassuccessful. Alternatively, where the programming was not successful, amessage may be sent to the mobile computing device 301 to indicate thatthe programming was unsuccessful. In block 909, the connection with themobile computing device 301 may be ended.

FIG. 6 is a process flow diagram illustrating an embodiment method 1000of patient modification of a programmed drug delivery regimen in animplantable drug delivery device. The method 1000 of FIG. 6 may beperformed by a patient programmer, such as a patient programmer unit 401as shown in FIGS. 1A and 1D, a combined patient programmer/telemetryunit 501 as shown in FIG. 1B, or a mobile computing device 601configured with patient programmer functionality as shown in FIG. 1C.The method 1000 may be performed by a processor of a patient programmerthat is coupled to a memory and configured with processor-executableinstructions for performing the various steps of the method. The memorymay contain stored parameters for allowable patient modifications to adrug delivery regimen, which may be programmed by a mobile computingdevice 301, as described above in connection with FIG. 4. Alternatively,all or a portion of the method 1000 may be performed by the implantabledrug delivery device 101, such as where the logic for determiningwhether a requested patient modification to the programmed drug deliveryregimen resides on the implantable device 101.

In block 1001 of method 1000, the patient programmer may detect an inputevent corresponding to a patient request for modification to aprogrammed drug delivery regimen. The input event may be, for example, abutton push by a patient on the patient programmer. The input event maycorrespond to a request for an additional dose of a drug (i.e., a bolusdose) from the implantable drug delivery device 101.

In block 1003 of method 1000, a determination may be made as to whetherthe requested modification is allowable based on at least one storedparameter. The stored parameter(s) may relate to the number of bolusdoses of a drug that a patient may request in a predetermined timeperiod, the volume of drug administered per bolus, a minimum wait timebetween administering bolus doses, time(s) of day in which bolus dosesmay be administered, etc. The parameters may have been previously set bya physician or other medical professional, and stored in memory of thepatient programmer. In determination block 1005, the processor of thepatient programmer may determine whether the requested modification isallowed. In response to determining the requested modification isallowed (i.e., determination block 1005=“Yes”), the processor of thepatient programmer may transmit the patient request to the implantabledrug delivery device 101 in block 1007. In determination block 1009, theprocessor of the patient programmer may determine whether a confirmationis received that the request has been successfully received andimplemented by the implantable drug delivery device 101. In response todetermining that the confirmation is received (i.e., determination block1009=“Yes”), the processor of the patient programmer may display thatthe patient request was successful in block 1011. In response to adetermination that the requested modification is not allowed (i.e.,determination block 1005=“No”), or in response to a determination thatno confirmation is received from the implantable device (i.e.,determination block 1009=“No”), the processor of the patient programmermay display that the patient request was unsuccessful in block 1013.

Various embodiments include a telemetry unit for an implantable drugdelivery device that may be coupled to a mobile computing device (e.g.,a smartphone, tablet, PDA, etc.) for programming of the implantable drugdelivery device. In some embodiments, after programming, the mobilecomputing device may be removed from the telemetry unit, and a patientprogrammer may be coupled to the telemetry unit for enabling patientrequested modifications to a programmed drug delivery regimen. In otherembodiments, after programming the mobile computing device may beremoved from the telemetry unit and a patient programmer may be coupledto a different telemetry unit for enabling patient requestedmodifications to the programmed drug delivery regimen. A firstembodiment of a telemetry unit 1101 is illustrated in FIGS. 7A-G. FIG.7A is an exploded view of the telemetry unit 1101 and a mobile computingdevice 301. FIG. 7B illustrates the telemetry unit 1101 coupled tomobile computing device 301. FIG. 7C is a cross-section view of thetelemetry unit 1101 and FIG. 7D is a rear view of the telemetry unit1101 coupled to the mobile computing device 301. As shown in thedrawings, the telemetry unit 1101 in this embodiment includes a bottomhousing 1103 that may include the transmitter/receiver element (e.g.,telemetry coils) for wireless communication with the implantable drugdelivery device, associated electronics and a power source (e.g., one ormore batteries). A top cover 1105 may be secured to the bottom housing1103, as shown in FIGS. 7B-D. A mobile computing device 301, such as asmartphone, may be mounted to the top cover 1105 as shown in FIGS. 7Band 7C. A three-way connector 1107 may be used to provide a data and/orpower connection (e.g, a USB bridge) between the mobile computing device301 and the telemetry unit 1101. The three-way connector 1107 may alsoinclude an external port 1109, such as a USB port. The top cover 1105and bottom housing 1103 may be secured using a suitable fasteningmechanism, such as internal crush pins. The top cover 1105 may be easilysecured to the bottom housing 1103 and removed from the bottom housing1103 by a user. Similarly, the top cover 1105 may be configured so thatthe mobile computing device 301 may easily snap into the top cover 1105to secure the device 301 to the top cover 1105 and can be easily removedfrom the top cover 1105 after use. In embodiments, the top cover 1105may be custom made to fit with a particular model of the mobilecomputing device 301. Various top covers 1105 may be made to fit withdifferent models of mobile computing devices. The top cover 1105 may bedesigned such that the mobile computing device 301 is fully operablewhile the device 301 is mounted to the top cover 1105. The top cover1105 may include one or more notches or cutouts 1111 at locationscorresponding with the locations of buttons or switches (e.g., a powerbutton) on the mobile computing device 301.

After the mobile computing device 301 has programmed the implantabledrug delivery device and/or collected data from the implantable device,the top cover 1105 may be removed from the bottom housing 1103 and themobile computing device 301 may be removed from the top cover 1105. Insome embodiments, a patient programmer 1113 may then be secured to thebottom housing 1103, as shown in FIGS. 7E-G. FIG. 7E shows the patientprogrammer 1113 before it is secured to the bottom housing 1103. FIG. 7Fis a front perspective view of the fully assembled telemetry unit 1101,and FIG. 7G is a rear view of the unit 1101. The patient programmer 1113and bottom housing 1103 may be secured using a suitable fasteningmechanism, such as internal crush pins. The patient programmer 1113 maybe easily secured to the bottom housing 1103 and removed from the bottomhousing 1103 as needed. The patient programmer 1113 includes a patientdosing button 1115 and LEDs 1117 that may provide indications of batterypower, whether the telemetry coils are in wireless range of theimplantable device, and whether a button push was successful. The button1115 and indicators 1117 may be electrically connected to theelectronics in the bottom housing 1103. The electronics for translatinga button push into a wireless transmission to the implantable drugdelivery device may be located in the patient programmer 1113 and/or thebottom housing 1103. Similarly, a processor and associated memory fordetermining whether a button push is allowable based on patientmodification parameters stored in the memory may be located in thepatient programmer 1113 and/or the bottom housing 1103.

A second embodiment of a telemetry unit 1201 is illustrated in FIGS.8A-G. FIG. 8A is an exploded view of the telemetry unit 1201 and amobile computing device 301. FIG. 8B illustrates the telemetry unit 1201coupled to mobile computing device 301. FIG. 8C is a cross-section viewof the telemetry unit 1201 and FIG. 8D is a rear view of the telemetryunit 1201 coupled to the mobile computing device 301. Similar to theembodiment of FIGS. 7A-G, the telemetry unit 1201 includes a bottomhousing 1203 that may include the transmitter/receiver element (e.g.,telemetry coils) for wireless communication with the implantable drugdelivery device, associated electronics and a power source (e.g., one ormore batteries). A top cover 1205, 1207 may secure over the bottomhousing 1203, as shown in FIGS. 8B-D. The top cover 1205, 1207 in thisembodiment may be a two-piece component, including a first piece 1205that receives the mobile computing device 103, and a bottom piece 1207that slides over the bottom of the mobile computing device 103 andprovides a three-way data/power connection between the mobile computingdevice 301, the bottom housing 1203 and an external port 1209, such as aUSB port. The top cover 1105 and bottom housing 1103 may be securedusing a suitable fastening mechanism, such as screws. In embodiments,the top cover portions 1205, 1207 may be custom made to fit with aparticular model of the mobile computing device 301. Various top covers1205, 1207 may be made to fit with different models of mobile computingdevices. The top cover 1205 may include one or more notches or cutouts1211 at locations corresponding with the locations of buttons orswitches (e.g., a power button) on the mobile computing device 301.

After the mobile computing device 301 has programmed the implantabledrug delivery device and/or collected data from the implantable device,the top cover portions 1105, 1107 may be removed from the bottom housing1203 and the mobile computing device 301 may be removed. In someembodiments, a patient programmer 1213, 1214 may then be secured to thebottom housing 1203, as shown in FIGS. 8E-G. FIG. 8E shows the patientprogrammer 1213, 1214 in an exploded view before it is secured to thebottom housing 1203. FIG. 8F is a front perspective view of the fullyassembled telemetry unit 1201, and FIG. 8G is a rear view of the unit1201. The patient programmer in this embodiment is a two-piece patientprogrammer that includes a top cover portion 1213, which may be securedto the bottom housing 1203 similar to the top cover 1205 shown in FIGS.8A-D, and a membrane keypad 1214 with an embossed dosing button 1215 andLED indicators 1217. The button 1215 and indicators 1217 may beelectrically connected to the electronics in the bottom housing 1203.The electronics for translating a button push into a wirelesstransmission to the implantable drug delivery device may be located inthe patient programmer 1213, 1214 and/or the bottom housing 1203.Similarly, a processor and associated memory for determining whether abutton push is allowable based on patient modification parameters storedin the memory may be located in the patient programmer 1213, 1214 and/orthe bottom housing 1203.

A third embodiment of a telemetry unit 1301 is illustrated in FIGS.9A-G. FIG. 9A is an exploded view of the telemetry unit 1301 and amobile computing device 301. FIG. 9B illustrates the telemetry unit 1301coupled to mobile computing device 301. FIG. 9C is a cross-section viewof the telemetry unit 1301 and FIG. 9D is a rear view of the telemetryunit 1301 coupled to the mobile computing device 301. Similar to theembodiments of FIGS. 7A-G and 8A-G, the telemetry unit 1301 includes abottom housing 1303 that may include the transmitter/receiver element(e.g., telemetry coils) for wireless communication with the implantabledrug delivery device, associated electronics and a power source (e.g.,one or more batteries). A top cover 1305 may secure over the bottomhousing 1303 to sandwich a mobile computing device 301 between the topcover 1305 and bottom housing 1303, as shown in FIGS. 9A-D. Theelectronics for data connection and charging may be contained in thebottom housing 1303. The top cover 1305 may include a slot or openingfor access to an external port 1309, such as a USB port. The top cover1205 and bottom housing 1203 may be secured using a suitable fasteningmechanism, such as screws. In embodiments, the top cover 1305 may becustom made to fit with a particular model of the mobile computingdevice 301. Various top covers 1305 may be made to fit with differentmodels of mobile computing devices. The top cover 1305 may include oneor more molded switches 1311 at locations corresponding with thelocations of buttons or switches (e.g., a power button) on the mobilecomputing device 301.

After the mobile computing device 301 has programmed the implantabledrug delivery device and/or collected data from the implantable device,the top cover 1305 may be removed from the bottom housing 1303 and themobile computing device 301 may be removed. In some embodiments, apatient programmer 1313 may then be secured to the bottom housing 1303,as shown in FIGS. 9E-G. FIG. 9E shows the patient programmer 1313 beforeit is secured to the bottom housing 1303. FIG. 9F is a front perspectiveview of the fully assembled telemetry unit 1301, and FIG. 9G is a rearview of the unit 1301. The patient programmer 1313 and bottom housing1303 may be secured using a suitable fastening mechanism, such asscrews. The patient programmer 1313 may be easily secured to the bottomhousing 1103 and removed from the bottom housing 1103 as needed. Thepatient programmer 1313 includes a patient dosing button 1315 and LEDs1317 that may provide indications of battery power, whether thetelemetry coils are in wireless range of the implantable device, andwhether a button push was successful. The button 1315 and indicators1317 may be electrically connected to the electronics in the bottomhousing 1303. The electronics for translating a button push into awireless transmission to the implantable drug delivery device may belocated in the patient programmer 1313 and/or the bottom housing 1303.Similarly, a processor and associated memory for determining whether abutton push is allowable based on patient modification parameters storedin the memory may be located in the patient programmer 1313 and/or thebottom housing 1303.

A fourth embodiment of a telemetry unit 1401 is illustrated in FIGS.10A-G. FIG. 10A is an exploded view of the telemetry unit 1401 and amobile computing device 301. FIG. 10B illustrates the telemetry unit1401 coupled to mobile computing device 301. FIG. 10C is a cross-sectionview of the telemetry unit 1401 and FIG. 10D is a rear view of thetelemetry unit 1401 coupled to the mobile computing device 301. Similarto the embodiments of FIGS. 7A-G, 8A-G and 9A-G, the telemetry unit 1401includes a bottom housing 1403 that may include the transmitter/receiverelement (e.g., telemetry coils) for wireless communication with theimplantable drug delivery device, associated electronics and a powersource (e.g., one or more batteries). A top cover 1405 may secure overthe bottom housing 1403 to sandwich a mobile computing device 301between the top cover 1405 and bottom housing 1403, as shown in FIGS.10A-D. A separate connector component 1407 containing a three-wayconnector and external (e.g., USB) port may attach to the top cover 1405and bottom housing 1403, as shown in FIGS. 10A-D. (The separateconnector component 1407 may not be used with the patient programmer1413 to reduce footprint). The top cover 1405 and bottom housing 1403may be secured using a suitable fastening mechanism, such as screws. Inembodiments, the top cover 1405 may be custom made to fit with aparticular model of the mobile computing device 301. Various top covers1405 may be made to fit with different models of mobile computingdevices. The top cover 1405 may include one or more molded switches 1411at locations corresponding with the locations of buttons or switches(e.g., a power button) on the mobile computing device 301.

After the mobile computing device 301 has programmed the implantabledrug delivery device and/or collected data from the implantable device,the top cover 1405 may be removed from the bottom housing 1403 and themobile computing device 301 may be removed. In some embodiments, apatient programmer 1413 may then be secured to the bottom housing 1403,as shown in FIGS. 10E-G. FIG. 10E shows the patient programmer 1413before it is secured to the bottom housing 1403. FIG. 10F is a frontperspective view of the fully assembled telemetry unit 1401, and FIG.10G is a rear view of the unit 1401. The patient programmer 1413 andbottom housing 1403 may be secured using a suitable fastening mechanism,such as screws. The patient programmer 1413 may be easily secured to thebottom housing 1403 and removed from the bottom housing 1403 as needed.The patient programmer 1413 includes a patient dosing button 1415 andLEDs 1417 that may provide indications of battery power, whether thetelemetry coils are in wireless range of the implantable device, andwhether a button push was successful. The button 1415 and indicators1417 may be electrically connected to the electronics in the bottomhousing 1403. The electronics for translating a button push into awireless transmission to the implantable drug delivery device may belocated in the patient programmer 1413 and/or the bottom housing 1403.Similarly, a processor and associated memory for determining whether abutton push is allowable based on patient modification parameters storedin the memory may be located in the patient programmer 1413 and/or thebottom housing 1403.

FIGS. 11A-11E are plots that illustrate various flow regimens that mayprogrammed into a drug delivery device and used to control the deliveryof a drug (the infusate) to a patient according to various embodiments.In FIGS. 11A-11D, volumetric flow rate of infusate is shown as afunction of time. FIG. 11A illustrates a drug delivery regimen featuringa constant flow rate 1501 over time. FIG. 11B illustrates a drugdelivery regimen featuring a flow rate 1503 that varies over time. FIG.11C illustrates a drug delivery regimen featuring a a basal flow rate1501 (which may be constant as shown in FIG. 11A or variable as shown inFIG. 11B) with periodic delivery of bolus doses 1515 of the drug, whichmay be delivered on a programmed basis and/or on an as-needed basis inresponse to a patient request. FIG. 11D illustrates a periodic drugdelivery regimen in which the infusate may be delivered via a programmedseries of delivery pulses 1507 (i.e., boluses), with no infusatedelivered between the delivery pulses 1507. The patient may optionallyhave the ability to administer additional bolus doses on an as-neededbasis.

A drug delivery regimen may include various combinations of one or moreof the flow rate schemes illustrated in FIGS. 11A-11D. In someembodiments, a particular dosage of infusate may be delivered in theform of a plurality of pulses or boluses of the infusate that provide atotal quantity of the dosage over a treatment period, as described incommonly-owned U.S. Pat. No. 9,180,282, which is incorporated byreference herein. The period between the boluses may be selected toprovide a prophylactic treatment to avoid granuloma formation in thetissue proximate to the delivery site.

Instead of a pre-programmed scheduled drug delivery regimen, a drugdelivery regimen may include delivery by user-selection of bolus dosesonly. This may be referred to as a user-selected bolus dose drugdelivery regimen. In such a regimen, the patient may control thedelivery of the bolus doses using a patient programmer unit, such aspatient programmer units 401, 501 and 601 described above with referenceto FIGS. 1A-1D. In this regimen, there may be no pre-programmedscheduled delivery of the drug to the patient, and the drug may bedelivered to the patient exclusively via user-requested bolus doses.

In some embodiments, the physician may program the patient programmerunit and/or the drug delivery device to adhere to certain parameters orlimits with respect to delivery of the infusate by bolus doses. Forexample, the programmed parameters may relate to the minimum wait time(i.e., refractory time) between the administration of bolus doses, thetotal number of bolus doses of a drug that the patient may administer ina predetermined time period (e.g., per day, per hour, per week, etc.),total quantity of drug that the patient may administer in apredetermined time period, time(s) of day in which bolus doses may beadministered, etc.

For example, with reference to FIG. 11D, the physician may program aminimum refractory time (t_(R)) following the delivery of apatient-requested bolus dose 1507 before the patient can successfullyrequest the delivery of another bolus dose. A request for another bolusdose within the minimum refractory time (t_(R)) will not be accepted(i.e., no infusate will be delivered by the drug delivery device inresponse to a patient request made on the patient programmer unit).Following the minimum refractory time (t_(R)), the patient maysuccessfully request another bolus dose.

FIG. 11E graphically illustrates a further embodiment in which a patientprogrammer unit may be configured to enable a patient to select aparticular size of bolus dose for delivery. For example, the patientprogrammer unit and/or the drug delivery device may be programmed toselectively deliver bolus doses of varying sizes (i.e., differentvolumes of the drug), such as the three sizes (1, 2, and 3) shown inFIG. 11E. The patient programmer unit may provide user-selectableoptions to enable a patient to select different size bolus doses (e.g.,via separate hard keys/buttons on the patient programmer unit and/or viauser-selectable menu options on a user interface display of the patientprogrammer unit). It will be understood that more or less than threedifferent size bolus doses may be utilized. Further, although thedifferent sizes of the bolus doses (i.e., sizes 1, 2 and 3) in FIG. 11Eare illustrated as having different volumetric flow rates 1509, 1511 and1513 over a given delivery time, t_(D), the bolus dose size may also beadjusted by varying the delivery periods, t_(D), or by varying the dutycycles of each bolus within a given delivery period, t_(D).

In some embodiments, the physician may define the various size(s) of thebolus doses and/or restrict the size(s) of the bolus available to thepatient when programming the device. The physician may further programlimits on the number and frequency of bolus dose administration. In someembodiments, the ability for a patient to select particular bolus size(i.e., 1, 2 or 3) at a given time may be a function of one or morepreviously administered bolus doses. For example, following theadministration of a relatively large dose (e.g., dose size 3), theminimum refractory time before the patient is allowed to administeranother dose may be longer than the minimum refractory time followingthe administration of a relatively smaller dose (e.g., dose size 1 or2). In addition, the minimum refractory time after a bolus dose isdelivered may be variable based on the size of the subsequentlyrequested bolus dose. For example, following the administration of afirst bolus dose (e.g., a size 1 bolus dose), the minimum refractorytime, t_(r), before another size 1 bolus dose is allowed to beadministered may be less than the minimum refractory time, t_(r), beforea larger (e.g., size 2 or 3) bolus dose may be administered.

The foregoing method descriptions and the process flow diagrams areprovided merely as illustrative examples and are not intended to requireor imply that the steps of the various embodiments must be performed inthe order presented. As will be appreciated by one of skill in the artthe order of steps in the foregoing embodiments may be performed in anyorder. Words such as “thereafter,” “then,” “next,” etc. are not intendedto limit the order of the steps; these words are simply used to guidethe reader through the description of the methods. Further, anyreference to claim elements in the singular, for example, using thearticles “a,” “an” or “the” is not to be construed as limiting theelement to the singular.

The various illustrative logical blocks, modules, circuits, andalgorithm steps described in connection with the embodiments disclosedherein may be implemented as electronic hardware, computer software, orcombinations of both. To clearly illustrate this interchangeability ofhardware and software, various illustrative components, blocks, modules,circuits, and steps have been described above generally in terms oftheir functionality. Whether such functionality is implemented ashardware or software depends upon the particular application and designconstraints imposed on the overall system. Skilled artisans mayimplement the described functionality in varying ways for eachparticular application, but such implementation decisions should not beinterpreted as causing a departure from the scope of the presentinvention.

The hardware used to implement the various illustrative logics, logicalblocks, modules, and circuits described in connection with theembodiments disclosed herein may be implemented or performed with ageneral purpose processor, a digital signal processor (DSP), anapplication specific integrated circuit (ASIC), a field programmablegate array (FPGA) or other programmable logic device, discrete gate ortransistor logic, discrete hardware components, or any combinationthereof designed to perform the functions described herein. Ageneral-purpose processor may be a microprocessor, but, in thealternative, the processor may be any conventional processor,controller, microcontroller, or state machine. A processor may also beimplemented as a combination of computing devices, e.g., a combinationof a DSP and a microprocessor, a plurality of microprocessors, one ormore microprocessors in conjunction with a DSP core, or any other suchconfiguration. Alternatively, some steps or methods may be performed bycircuitry that is specific to a given function.

In one or more exemplary embodiments, the functions described may beimplemented in hardware, software, firmware, or any combination thereof.If implemented in software, the functions may be stored as one or moreinstructions or code on a non-transitory computer-readable medium ornon-transitory processor-readable medium. The steps of a method oralgorithm disclosed herein may be embodied in a processor-executablesoftware module that may reside on a non-transitory computer-readable orprocessor-readable storage medium. Non-transitory computer-readable orprocessor-readable storage media may be any storage media that may beaccessed by a computer or a processor. By way of example but notlimitation, such non-transitory computer-readable or processor-readablemedia may include RAM, ROM, EEPROM, FLASH memory, CD-ROM or otheroptical disk storage, magnetic disk storage or other magnetic storagedevices, or any other medium that may be used to store desired programcode in the form of instructions or data structures and that may beaccessed by a computer. Disk and disc, as used herein, includes compactdisc (CD), laser disc, optical disc, digital versatile disc (DVD),floppy disk, and blu-ray disc where disks usually reproduce datamagnetically, while discs reproduce data optically with lasers.Combinations of the above are also included within the scope ofnon-transitory computer-readable and processor-readable media.Additionally, the operations of a method or algorithm may reside as oneor any combination or set of codes and/or instructions on anon-transitory processor-readable medium and/or computer-readablemedium, which may be incorporated into a computer program product.

The preceding description of the disclosed aspects is provided to enableany person skilled in the art to make or use the present invention.Various modifications to these aspects will be readily apparent to thoseskilled in the art, and the generic principles defined herein may beapplied to other aspects without departing from the scope of theinvention. Thus, the present invention is not intended to be limited tothe aspects shown herein but is to be accorded the widest scopeconsistent with the principles and novel features disclosed herein.

What is claimed is:
 1. A method for communicating with an implantabledrug delivery device using a mobile computing device, comprising:establishing a connection with a telemetry unit configured for wirelesscommunication with the implantable drug delivery device; displayinguser-selectable drug delivery settings for the implantable drug deliverydevice; receiving at least one selection of a drug delivery setting;translating the received selection into a signal format readable by thetelemetry unit; and sending the translated signal to the telemetry unitto program the implantable drug delivery device.
 2. The method of claim1, wherein the mobile computing device comprises a mobile phone, atablet computer or a PDA.
 3. The method of claim 1, wherein the mobilecomputing device establishes the connection with the telemetry unitwhile the mobile computing device is physically coupled to the telemetryunit, the method further comprising ending the connection with thetelemetry unit when the mobile computing device is physically removedfrom the telemetry unit.
 4. The method of claim 3, wherein the mobilecomputing device is physically coupled to the telemetry unit by beingsecured within a housing of the telemetry unit.
 5. The method of claim3, wherein the connection with the telemetry unit is a wirelessconnection comprising one or more of a near field communication (NFC)connection or a personal area network (PAN) connection.
 6. The method ofclaim 1, further comprising: receiving data from the implantable drugdelivery device, via the connection with the telemetry unit.
 7. Themethod of claim 6, wherein the data comprises at least one of dataregarding a status of the implantable drug delivery device,physiological data of a patient in which the drug delivery device isimplanted, and data regarding the programming of the implantable drugdelivery device.
 8. The method of claim 1, further comprising:authenticating at least one of the mobile computing device and a user ofthe mobile computing device as being authorized to program theimplantable drug delivery device prior to programming of the implantabledrug delivery device.
 9. The method of claim 1, further comprising:establishing a connection with a remote computing device over atelecommunications network, wherein the at least one selection of a drugdelivery setting is received from the remote computing device over thetelecommunications network.
 10. The method of claim 1, furthercomprising: establishing a connection with a patient programmer;displaying user-selectable settings for the patient programmer;receiving a selection of at least one parameter for patient modificationof a drug delivery regimen programmed at the implantable drug deliverydevice; and transmitting the at least one selected parameter to thepatient programmer to program the patient programmer.
 11. The method ofclaim 10, wherein the patient programmer is a separate unit capable ofestablishing a connection with a telemetry unit.
 12. The method of claim11, wherein the patient programmer is a second mobile computing device.13. The method of claim 10, wherein the patient programmer is anintegral component of the telemetry unit.
 14. The method of claim 10,wherein the connection with the patient programmer is a wirelessconnection, comprising one or more of a near field communication (NFC)connection, a personal area network (PAN) connection, a WiFi connectionand a wireless connection over a telecommunications network.
 15. Themethod of claim 10, wherein the at least one parameter for patientmodification of a drug delivery regimen comprises at least one of anumber of bolus doses of a drug that a patient may request in apredetermined time period, a volume of drug administered per bolus, aminimum wait time between administering bolus doses, a time of day inwhich bolus doses may be administered, and an allowable modification toa basal rate of drug delivery that a patient may request.
 16. A methodfor patient modification to a programmed drug delivery regimen in animplantable drug delivery device, comprising: establishing a connectionwith a computing device; receiving from the computing device at leastone parameter for patient modification of the programmed drug deliveryregimen; storing the at least one parameter in a memory; detecting aninput event corresponding to a patient request for modification to theprogrammed drug delivery regimen; determining whether the requestedmodification is allowed based on the stored at least one parameter; andtransmitting the patient request to the implantable drug delivery devicewhen it is determined that the requested modification is allowed. 17.The method of claim 16, wherein the method is performed by a patientprogrammer unit that is separate from the computing device, the methodfurther comprising: establishing a connection with a telemetry unitconfigured for wireless communication with the implantable drug deliverydevice, the patient request being transmitted to the implantable drugdelivery device via the telemetry unit.
 18. The method of claim 17,wherein the computing device comprises a first mobile computing deviceand the patient programmer unit comprises a second mobile computingdevice.
 19. The method of claim 16, wherein the method is performed by acombined patient programmer/telemetry unit configured for wirelesscommunication with the implantable drug delivery device.
 20. The methodof claim 17, wherein the patient programmer unit establishes theconnection with the telemetry unit while the patient programmer unit isphysically coupled to the telemetry unit, the method further comprisingending the connection with the telemetry unit when the patientprogrammer unit is physically removed from the telemetry unit.
 21. Themethod of claim 16, wherein the connection with the computing device isa wireless connection comprising one or more of a near fieldcommunication (NFC) connection, a personal area network (PAN)connection, a WiFi connection and a wireless connection over atelecommunications network.
 22. The method of claim 16, wherein the atleast one parameter for patient modification of a drug delivery regimencomprises at least one of a number of bolus doses of a drug that apatient may request in a predetermined time period, a volume of drugadministered per bolus, a minimum wait time between administering bolusdoses, a time of day in which bolus doses may be administered, and anallowable modification to a basal rate of drug delivery that a patientmay request.
 23. The method of claim 16, further comprising: displayingfeedback to a patient regarding the status of a patient request tomodify the programmed drug delivery regime.
 24. The method of claim 16,wherein programmed drug delivery regimen comprises a user-selected bolusdose drug delivery regimen and the at least one parameter comprises atleast one of a minimum wait time between the administration of bolusdoses, a total number of bolus doses that may be administered in apre-determined time period and a total quantity of a drug that may beadministered in a pre-determined time period.
 25. The method of claim24, wherein the at least one parameter further comprises a plurality ofdifferent sizes of bolus doses that a patient is permitted to request.26. The method of claim 25, wherein the at least one parameter defineslimits on the ability of a patient to administer a bolus dose of aparticular size based on one or more previously-administered bolusdoses.
 27. A patient programmer device, comprising: a user-inputcomponent; a communication module; a memory; and a processor coupled tothe user-input component, the communication module, and the memory, theprocessor configured with processor-executable instructions to performoperations comprising: establishing a connection with a second computingdevice; receiving from the second computing device at least oneparameter for patient modification of a programmed drug delivery regimenin an implantable drug delivery device; storing the at least oneparameter in a memory; detecting an input event corresponding to apatient request for modification to the programmed drug deliveryregimen; determining whether the requested modification is allowed basedon the stored at least one parameter; and transmitting the patientrequest to the implantable drug delivery device in response todetermining that the requested modification is allowed.